Overview

Many Americans fear that participating in research or undergoing genetic testing will lead to them being discriminated against based on their genetics. Such fears may dissuade patients from volunteering to participate in the research necessary for the development of new tests, therapies and cures, or refusing genomics-based clinical tests. To address this, in 2008 the Genetic Information Nondiscrimination Act was passed into law, prohibiting discrimination in the workplace and by health insurance issuers. In addition, there are other legal protections against genetic discrimination by employers, issuers of health insurance, and others.

The Genetic Information Nondiscrimination Act of 2008

GINA protects Americans from discrimination based on their genetic information in both health insurance (Title I) and employment (Title II). Title I amends the Employee Retirement Income Security Act of 1974 (ERISA), the Public Health Service Act (PHSA), and the Internal Revenue Code (IRC), through the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as well as the Social Security Act, to prohibit health insurers from engaging in genetic discrimination.

Health Insurance (Title I)

GINA prohibits issuers of health insurance from discrimination on the basis of the genetic information of enrollees. Specifically, health insurance issuers may not use genetic information to make eligibility, coverage, underwriting or premium-setting decisions. Furthermore, issuers may not request or require individuals or their family members to undergo genetic testing or to provide genetic information. As defined in the law, genetic information includes family medical history and information regarding individuals' and family members' genetic tests.

See these resources for additional information on the law:

GINA and Clinical Research

GINA has implications for individuals participating in research studies. The Office of Human Research Protections (OHRP) within the Department of Health and Human Services has issued guidance on integrating GINA into clinical research, including information on GINA's research exemption, considerations for Institutional Review Boards, and integrating information on GINA into informed consents.

Informed Consent Forms
To comply with GINA, informed consent forms should include information on any risks associated with participation in the research project and a statement describing how the confidentiality of records will be maintained. NHGRI has developed guidance for informed consent forms for participants in genomics research.

Both cases alleged that the employer illegally included questions about family medical histories in pre-employment medical exams. In the first, the fabrics manufacturer Fabricut agreed to pay $50,000 compensation and provide antidiscrimination training to employees after a prospective employee was asked for their family medical history during a post-offer medical exam. In the second suit, a New York nursing and rehabilitation center, Founders Pavilion Inc., was similarly accused of requesting family medical histories during medical exams. Under GINA, it is illegal for companies to ask their employees for genetic information, which includes family medical history.

Where GINA Does Not Apply

GINA does not apply to employers with fewer than 15 employees. GINA's protections in employment do not extend to the US military. Nor does it apply to health insurance through the TRICARE military health system, the Indian Health Service, the Veterans Health Administration, or the Federal Employees Health Benefits Program. Lastly, the law does not cover long term care insurance, life insurance or disability insurance. (Note: Beyond GINA, additional laws and policies do offer additional protections against genetic discrimination: See Genetic Discrimination and Other Laws.)

Genetic Discrimination and Other Laws

Bill Clinton's Executive Order Prohibiting the Use of Genetic Information in Federal Worker Employment (2000)

On February 8, 2000, Bill Clinton issued Executive Order 13145, prohibiting discrimination in Federal employment based on genetic information. The Executive Order prohibits federal employers from requesting or requiring any genetic information from their employees, or the use of genetic information in any employment decision. (At the time of releasing this executive order, he expressed support for a federal law prohibiting genetic discrimination by private employers or health insurance issuers.)

The Affordable Care Act

A major provision of The Affordable Care Act of 2010 (ACA) [healthcare.gov] is to establish 'guaranteed issue'; issuers offering insurance in either the group or individual market must provide coverage for all individuals who request it. The law therefore prohibits issuers of health insurance from discriminating against patients with genetic diseases by refusing coverage because of 'pre-existing conditions'. ACA further provides additional protections for patients with genetic diseases by establishing that certain health insurance issuers may only vary premiums based on a few specified factors such as age or geographic area, thereby prohibiting the adjustment of premiums because of medical conditions.

Note: Under GINA, health insurance issuers are prohibited from using a person's genetic information for underwriting, but GINA provides no such protections for individuals with a "manifest disease" - requiring a provider of health insurance to issue coverage for an individual with a genetic disease.

The Americans with Disabilities Act

The Americans with Disabilities Act (ADA) [ada.gov] prohibits discrimination in employment, public services, accommodations, and communications based on a disability. In 1995, the Equal Employment Opportunity Commission (EEOC) issued an interpretation that discrimination based on genetic information relating to illness, disease, or other disorders is prohibited by the ADA. In a subsequent Senate hearing in 2000, EEOC Commissioner Paul Miller further affirmed that the ADA "can be interpreted to prohibit employment discrimination based on genetic information." However, these EEOC opinions are not legally binding, and whether the ADA protects against genetic discrimination in the workplace has never been tested in court. For more information, see: The Genetic Information Nondiscrimination Act of 2008 (GINA) .

The ADA has, however, been used to challenge genetic testing practices by an employer. In 2001, EEOC filed a suit against the Burlington Northern Santa Fe (BNSF) Railroad for secretly testing its employees for a rare genetic condition (hereditary neuropathy with liability to pressure palsies - HNPP) that causes carpal tunnel syndrome as one of its many symptoms. BNSF claimed that the testing was a way of determining whether the high incidence of repetitive-stress injuries among its employees was work-related. Besides testing for HNPP, company-paid doctors also were instructed to screen for several other medical conditions such as diabetes and alcoholism. A medicated settlement was announced by the EEOC and BNSF in 2002.

Policies pertaining to Federal Employees, U.S. Military, Veterans, and the Indian Health Service

GINA does not apply to individuals who receive their insurance through the Federal Employees Health Benefits, the Veterans Health Administration, the U.S. Military (TRICARE), and the Indian Health Service because Title I of GINA amends laws that do not have jurisdiction over these groups. However, some of these programs have internal policies that prohibit or restrict genetic discrimination.

Federal Employees Health Benefits
The Office of Personnel Management, which administers the FEHB program, requires all participating insurers and plans to accept all enrolees regardless of health status. For more information, see: www.opm.gov/INSURE/HEALTH/INDEX.ASP

Veterans Health Administration and the U.S. Military
For many years, the Department of Defense could deny benefits to a soldier or veteran who developed an illness of a known genetic basis after enlistment. In 1990, the Veterans Health Administration changed its policy and began covering genetic or hereditary conditions that manifest after enrollment, because they could be "service aggravated". In 2008, the US Military followed suit and adopted the same policy for service members under TRICARE coverage. See these resources for additional information about these policies:

Indian Health Affairs
The Department of Indian Health Affairs is tasked with providing healthcare to all American Indians and Alaskan Natives under its treaty obligations. However, Indian Health Affairs often experiences shortfalls in funding, meaning that some services are not available in practice. For more information, see: www.ihs.gov

State Laws

A patchwork of state laws exists to protect Americans from genetic discrimination, although these laws vary widely in the scope, applicability, and amount of protection provided. The earliest state laws focused on particular genetic conditions. For example, North Carolina was the first state to prohibit discrimination based on the presence of the sickle cell trait. In 1991, Wisconsin was the first state to prevent whole-sale discrimination based on genetic tests. At present, 48 states and the District of Columbia have passed laws preventing genetic discrimination in health insurance providers and 35 states and the District of Columbia prevent genetic discrimination in employment. GINA sets a floor of minimum protection against genetic discrimination and does not preempt state laws with stricter protections. At present, 15 states have additional laws restricting the use of genetic information in determining coverage for life insurance, 17 states for disability insurance, and nine states for long-term care insurance.

Legislative History of GINA

In 1995, Congresswoman Louise Slaughter (D-NY) and Senator Olympia Snowe (R-ME) introduced the first federal legislation limiting genetic discrimination, The Genetic Information Nondiscrimination Act in Health Insurance of 1995. They envisioned the bill, ideally passed by the completion of the Human Genome Project, would allay public fears of genetic discrimination, promote public participation in medical research, and prevent genetic discrimination. The original bill failed to pass either the House of Representatives or Senate. Variations on this legislation, ultimately expanding to include protection in employment, were introduced in each subsequent Congress, and the bills enjoyed broad bipartisan support in both House and Senate. The Senate passed the bill unanimously in consecutive Congresses, but it did not become law because of inaction in the House. The Genetic Information Nondiscrimination Act of 2008 ultimately passed the House and Senate and was signed into law by President George W. Bush on May 21, 2008.

104th Congress (1995 - 1996)

The first national legislation barring genetic discrimination was introduced in the 104th Congress of 1995-1996. There were several related pieces of legislation: The Genetic Information Nondiscrimination In Health Insurance Act of 1995 (H.R. 2748/S. 1694) introduced into the House by Rep. Louise Slaughter (D-NY) and the Senate by Sen. Olympia Snowe (R-ME); The Genetic Privacy and Nondiscrimination Act of 1995 (H.R. 2690/S. 1416) introduced in the House by Rep. Clifford Stearns (R-FL) and Sen. Mark Hatfield (R-OR); The Genetic Fairness Act of 1996 (S.1600) introduced by Sen. Dianne Feinstein (D-CA); and the Genetic Confidentiality and Nondiscrimination Act of 1996 (S.1898) introduced by Sen. Pete Domenici (R-NM). None of these bills were passed into law.

107th Congress (2001 - 2002)

Once again, Rep. Slaughter (D-NY) and Sen. Snowe (R-ME) introduced legislation barring genetic discrimination in the 107th Congress. Rep. Slaughter introduced the Genetic Nondiscrimination in Health Insurance and Employment Act (H.R. 602), which had 266 co-sponsors. Sen. Snowe introduced The Genetic Information Nondiscrimination in Health Insurance Act (S. 382), which had six co-sponsors. Sen. Daschle (D-SD) attempted to introduce protection against genetic discrimination in two pieces of legislation: as Title IV of the Protecting Civil Rights for All Americans Act ( S. 19) and the Genetic Nondiscrimination in Health Insurance and Employment Act (S. 318). None of these bills were passed.

108th Congress (2003 - 2004)

The tides were starting to turn by the 108th Congress. Sen. Snowe (R-ME) introduced the Genetic Information Nondiscrimination Act of 2003 (S. 1053), which passed the Senate 95-0. The bill was not taken up by the House. Several other pieces of legislation were introduced, but not passed: The Bipartisan Patient Protection Act of 2004 ( S. 2083) introduced by Sen. Boxer (D-CA); The Genetic Nondiscrimination in Health Insurance and Employment Act (H.R. 1910) introduced by Rep. Slaughter (D-NY); the Genetic Privacy and Nondiscrimination Act of 2003 ( H.R. 3636) introduced by Rep. Stearns (R-FL); and the Equal Rights and Equal Dignity for Americans Act of 2003 (S. 16) introduced by Sen. Daschle (D-SD).

109th Congress (2005 - 2006)

Once again, The Genetic Information Nondiscrimination Act of 2005 (S. 306) introduced by Sen. Snowe (R-ME) was passed in the Senate 98-0. A related bill, H.R. 1227, was co-introduced in the House by Reps. Slaughter (D-NY) and Biggert (R-IL), but was not voted on.

110th Congress (2007 - 2008)

After 13 years of legislative effort, The Genetic Information Nondiscrimination Act of 2008 was signed into law by President George W. Bush on May 21, 2008, becoming Public Law 110-233. The bill was introduced in the House (H.R. 493) by Rep. Slaughter and in the Senate ( S. 358) by Sen. Snowe. The bill passed the House by a vote of 414-1 and passed the Senate unanimously 95-0.